Starck Sefam S.Box Patient Manual
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Starck Sefam S.Box Patient Manual

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  • Page 2  Easily monitor the evolution of the effectiveness of your treatment and other parameters of your health and well-being,  Share this data with your healthcare professionals,  Get access to information about your S. Box. With SEFAM ACCESS, engage in your treatment ! www.SEFAM-medical.com 2  SEFAM S.Box...

  • Page 3: Table Of Contents

    Humidifier performance ..........................33 Conditions of use ............................34 Transporting and storage conditions ...................... 34 Electrical characteristics ..........................34 Physical characteristics ..........................35 CE marking ..............................35 Regulatory Requirements .......................... 35 End-of-life disposal of the device ......................36 SEFAM S.Box Contents  3...

  • Page 4: Before You Start

    WARNING: to yourself or others.  The SEFAM S.Box can only be used on prescription. Under no circumstances should you change the prescribed settings without the agreement of your healthcare professional.  Use the device only for the prescribed use as indicated in this manual. The advice given in this manual does not replace the instructions of your healthcare professional.

  • Page 5: When Traveling

    The S.Box heated humidifier is an accessory designed to warm and add moisture to the air flow delivered to the patient by the SEFAM S.Box device, for the treatment of Obstructive Sleep Apnea– Hypopnoea Syndrome (OSAHS). It is intended for use by adult patients in either the homecare or the hospital environment.

  • Page 6: Contra-Indications

    (Epistaxis), discomfort or pain in the ear or sinuses, bloating, daytime sleepiness, mood changes, disorientation, irritability or loss of memory. Components of the system The SEFAM S.Box comes with the following components: S.Box SD card Side cover ...

  • Page 7: Description

    Intended for use by your doctor or Home Care Provider. Air inlet filter and grid: Prevent dust from entering the device and the air flow path. Power port: To power the device by the power supply or by a cigarette lighter. SEFAM S.Box Description  7...

  • Page 8: Definition Of Symbols

    "Keep dry" because the means "Fragile" because package must be protected against package must be handled with care. moisture and water. On the packaging, this symbol Refer to the user manual. means "Temperature limit". 8  Description SEFAM S.Box...

  • Page 9: Installation

    "click". WARNING: If the heated humidifier is not properly installed, there is a risk of air loss which can cause a variation of the applied pressure versus the prescribed pressure. SEFAM S.Box Installation  9...

  • Page 10: Installation For Power Via The Cigarette Lighter

    Use only the 24 V cigarette lighter cable recommended with the device.  Assure the conformity of the voltage supplied by the cigarette lighter socket.  Do not use the device with a 12 V or 13 V battery of a light vehicle. 10  Installation SEFAM S.Box...

  • Page 11: Use

    Filling the humidifier chamber (if installed) 1. Unplug the SEFAM S.Box device from the power supply or the electrical power grid. 2. To separate the humidifier chamber from the device, press the button to unlock the humidifier chamber (mark 4 in Figure 1) and at the same time, pull the humidifier chamber away from the device using the integrated handle.

  • Page 12: Stopping Treatment

    The symbol is displayed in the status bar. The ramp starts automatically when the apparatus is switched on (if the ramp time is not zero). It can be deactivated by pressing the ramp button 12  Use SEFAM S.Box...

  • Page 13: Using An Sd Card

    CAUTION: It is absolutely necessary that you empty the humidifier chamber before moving or transporting the device, in order to prevent any risk of water entering the machine, which can cause irreversible damage. SEFAM S.Box Use  13...

  • Page 14: Information And Settings

    General organization of the display From top to bottom, the display is organized in three parts:  a status bar  a setting area  a space with 8 touch keys and the symbol displayed on power-up. 14  Information and settings SEFAM S.Box...
  • Page 15 Touch key to adjust the S.Box Touch key to adjust the heated heated tube with ATC setting humidifier setting Touch key to access the settings Touch key to access information Multifunctional touch key Home touch key SEFAM S.Box Information and settings  15...

  • Page 16: How To Set The Device

    Possible displays: LK:OK, LK:NOK. in standby mode. In case of undesired leak (LK:NOK), re- adjust your mask. to return to the standby screen. The display will turn off automatically after two minutes without tapping a key. 16  Information and settings SEFAM S.Box...
  • Page 17 Possible settings: from 4 cm H O to the pressure set in  CPAP mode.  from 4 cm H O to the maximum pressure set in APAP (Auto-CPAP) mode. SEFAM S.Box Information and settings  17...
  • Page 18 Nonin pulse oximeter on the SD card  to recover compliance data recorded in the device via a Bluetooth connection  to make adjustments via tablet / smartphone applications (refer to the corresponding instructions for use). 18  Information and settings SEFAM S.Box...
  • Page 19 You can deactivate (OFF) or activate (ON) Tap the touch key the Wi-Fi module connection by tapping the key Possible settings: WIFI: ON and WIFI: OFF. The symbol blinks slowly at the top of the screen. SEFAM S.Box Information and settings  19...
  • Page 20 Only when the Wi-Fi module is installed inside the SEFAM S.Box device and the Wi-Fi connection activated, you can access the WPS automatic configuration which allows connecting to the local network. Tap the touch Views of the display: Tap the touch...
  • Page 21 A period of 24-hour use is set from noon to the next noon. Accessing a period of use ❶ Tap the touch key This screen appears only if at least two periods of 24-hour use have been recorded in the device. in standby mode. SEFAM S.Box Information and settings  21...
  • Page 22 24-hour use. Usage hour counter: time during which you ❺ have been breathing in the mask during the Tap the touch key period of use. 22  Information and settings SEFAM S.Box...
  • Page 23 4 hours per day Tap the touch key (within the limit of 30 days) This screen appears only if the number of 24-hour periods recorded in the device is more than 01. SEFAM S.Box Information and settings  23...
  • Page 24 It can be read but not modified. Total usage hour counter ⓭ Tap the touch key This counter calculates the total time during which you have been breathing into the mask. 24  Information and settings SEFAM S.Box...
  • Page 25 When you are using SEFAM ACCESS application on a Bluetooth enabled device (such as a Smartphone or a tablet) and you connect it to the SEFAM S.Box in standby mode via Bluetooth wireless communication, a message appears on the display of the machine at the first pairing:...
  • Page 26 PolyLink system, S.Box modem or S.Box Wi-Fi module. Otherwise, follow the instructions in the settings menu and set these connections on OFF. The SEFAM S.Box device complies with the Federal Aviation Administration RTCA/DO-160G section 21 category M.

  • Page 27: Using The Device When Adding Oxygen (Optional)

    2. Similarly, in order to prevent oxygen from entering the device, it is essential to stop the flow of oxygen before switching off the device. SEFAM S.Box Using the device when adding oxygen (optional)  27...

  • Page 28: Cleaning And Maintenance

    Fill the bottom part of the humidifier chamber, then press down on the upper part to close the chamber and lock it. Place the humidifier chamber back on the heater plate, hinge side towards the inside of the machine, and push it against the device until you hear a "click". 28  Cleaning and Maintenance SEFAM S.Box...

  • Page 29: Monthly

     Never use concentrated bleach higher than 0.1%. For example: pour 200 ml of bleach to 2.6% in 5 liters of cold water. SEFAM S.Box Cleaning and Maintenance  29...

  • Page 30: In Case Of Problems

    (see correct pressure on section "How to set the device" page 16). the display. The selected ramp Contact your Home Care Provider. does not suit you. 30  In case of problems SEFAM S.Box...
  • Page 31 Water was spilled Unplug the device and allow it to dry for at least into the device. 24 hours. Reconnect the device and make sure it is working properly. SEFAM S.Box In case of problems  31...

  • Page 32: Device Messages

    Disconnect the power supply from the mains. Plug it in operating error. again and turn on the device. If the error persists, contact your Home Care Provider. The error code blinks. (XX = 2 figures). 32  In case of problems SEFAM S.Box...

  • Page 33: Technical Characteristics

    11 ml / kPa (humidifier chamber empty) 8 ml / kPa (humidifier chamber full) Maximum operating pressure: 20 cm H Maximum gas temperature coming from the breathing 43°C tube: Values determined under ATPD (Ambient Temperature and Pressure, Hygrometry) conditions. SEFAM S.Box Technical characteristics  33...

  • Page 34: Conditions Of Use

    75 W during a mask disconnection Current consumption at 20 cmH O with a 4- 0.42 A (minimum configuration: SEFAM S.Box only) mm leak: 1.99 A (maximum configuration: SEFAM S.Box with humidifier set to 10 and heated tube set to 05) ®...

  • Page 35: Physical Characteristics

    Risks concerning this medical device are evaluated according to the ISO 14971 standard, specifically with regard to global residual risk. The SEFAM S.Box complies with the following Directives and standards:  Directive 93/42/CEE of the European Parliament and of the Council concerning medical devices, modified by the European Directive 2007/47/CE.

  • Page 36: End-Of-Life Disposal Of The Device

    "Definition of symbols" page 8). In other countries, this device must be processed following local regulation. Unsuitable disposal of the device at the end of its life could harm the environment. Contact your home care provider. 36  Technical characteristics SEFAM S.Box...
  • Page 38 Contact of your Home Care Provider Manufacturer: Manufacturing plant: SEFAM SEFAM 144 AV CHARLES DE GAULLE 10 ALLÉE PELLETIER DOISY 92200 NEUILLY SUR SEINE 54600 VILLERS-LES-NANCY FRANCE FRANCE : M-164DFU00-20-Version 3 2017-11...

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